| Device Type ID | 2550 |
| Device Name | Syringe, Piston |
| Regulation Description | Piston Syringe. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FMF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2550 |
| Device | Syringe, Piston |
| Product Code | FMF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Piston Syringe. |
| CFR Regulation Number | 880.5860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AEA SRL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANUTRA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAXTER HEALTHCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAXTER HEALTHCARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET SPINE (AKA EBI, LLC) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BONE SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELI LILLY AND CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELI LILLY AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JIANGYIN CAINA TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
JMS NORTH AMERICA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
NAVILYST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIPRO CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIPRO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVO NORDISK INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PINNACLE SPINE GROUP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROCEDURE PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROFIBRIX BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHINA MED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOL-MILLENNIUM MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINAL SURGICAL STRATEGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO EUROPE N.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U&U MEDICAL TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UROGEN PHARMA LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZIMMER KNEE CREATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 242 |
Leak / Splash | 162 |
Device Operates Differently Than Expected | 108 |
Break | 98 |
Fluid Leak | 93 |
Infusion Or Flow Problem | 70 |
Physical Property Issue | 64 |
Device Contaminated During Manufacture Or Shipping | 60 |
Device Markings / Labelling Problem | 55 |
Device Damaged Prior To Use | 40 |
Failure To Deliver | 40 |
Crack | 38 |
Mechanical Problem | 38 |
Material Deformation | 37 |
Insufficient Information | 35 |
Material Twisted / Bent | 35 |
Product Quality Problem | 32 |
Material Integrity Problem | 31 |
Device Operational Issue | 31 |
Delivered As Unsterile Product | 30 |
Bent | 28 |
Manufacturing, Packaging Or Shipping Problem | 28 |
Volume Accuracy Problem | 26 |
None | 25 |
Holder | 18 |
Dull, Blunt | 18 |
No Flow | 17 |
Use Of Device Problem | 15 |
Detachment Of Device Component | 15 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Syringe | 13 |
Component Missing | 13 |
Detachment Of Device Or Device Component | 13 |
Improper Flow Or Infusion | 12 |
Inaccurate Delivery | 12 |
Defective Device | 12 |
Rod | 12 |
Obstruction Of Flow | 12 |
Packaging Problem | 11 |
Appropriate Term/Code Not Available | 10 |
Backflow | 10 |
Delivery System Failure | 9 |
Complete Blockage | 9 |
Mechanical Jam | 9 |
Needle | 8 |
Labelling, Instructions For Use Or Training Problem | 8 |
Occlusion Within Device | 8 |
Device Difficult To Setup Or Prepare | 8 |
Mechanism | 8 |
Improper Or Incorrect Procedure Or Method | 8 |
Defective Component | 7 |
Contamination During Use | 7 |
Material Puncture / Hole | 7 |
Fail-Safe Problem | 7 |
Switch, Push Button | 7 |
Material Fragmentation | 7 |
Sticking | 7 |
Contamination / Decontamination Problem | 6 |
Connection Problem | 6 |
Device Inoperable | 6 |
Tear, Rip Or Hole In Device Packaging | 6 |
Failure To Fire | 6 |
Material Frayed | 5 |
Particulates | 5 |
Physical Resistance / Sticking | 5 |
Excess Flow Or Over-Infusion | 5 |
Piston Guides | 5 |
Material Protrusion / Extrusion | 5 |
Plunger | 5 |
Difficult Or Delayed Activation | 5 |
Display | 5 |
Incorrect Or Inadequate Test Results | 4 |
Kinked | 4 |
Disconnection | 4 |
Mechanics Altered | 4 |
Hole In Material | 4 |
Partial Blockage | 4 |
No Display / Image | 4 |
Device Dislodged Or Dislocated | 4 |
Cannula | 4 |
Pusher | 3 |
Activation, Positioning Or Separation Problem | 3 |
Failure To Prime | 3 |
Device Misassembled During Manufacturing / Shipping | 3 |
Device Subassembly | 3 |
Injection System | 3 |
Device Handling Problem | 3 |
Moisture Or Humidity Problem | 3 |
Calibration Problem | 3 |
Device Expiration Issue | 3 |
Nonstandard Device | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Device Slipped | 2 |
Spring Loading Mechanism | 2 |
Restricted Flow Rate | 2 |
Piston Pads | 2 |
Short Fill | 2 |
Off-Label Use | 2 |
Device Issue | 2 |
Needle, Separation | 2 |
| Total Device Problems | 1958 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Baxter Corporation Englewood | II | Jan-30-2016 |
| 3 | Baxter Corporation Englewood | II | May-14-2014 |
| 4 | Becton Dickinson & Company | II | Nov-28-2017 |
| 5 | Becton Dickinson & Company | II | Jul-19-2017 |
| 6 | Becton Dickinson & Company | II | Jun-09-2016 |
| 7 | Becton Dickinson & Company | II | Feb-05-2015 |
| 8 | Biomet, Inc. | II | May-25-2016 |
| 9 | Cypress Medical Products LLC | II | Oct-16-2018 |
| 10 | Ethicon, Inc. | II | Apr-26-2018 |
| 11 | Integra LifeSciences Corp. D.b.a. Integra Pain Management | II | Oct-30-2015 |
| 12 | International Medsurg Connection, Inc. | II | Aug-04-2017 |
| 13 | Medela Inc. EF Division | II | Mar-11-2015 |
| 14 | Merit Medical Systems, Inc. | II | Aug-10-2018 |
| 15 | Merit Medical Systems, Inc. | II | Apr-27-2017 |
| 16 | Merit Medical Systems, Inc. | II | Apr-03-2014 |
| 17 | Novo Nordisk Inc | II | Dec-07-2017 |
| 18 | Owen Mumford USA, Inc. | II | Jul-15-2015 |
| 19 | ShinChang Medical Co., Ltd. | II | Sep-20-2018 |
| 20 | Terumo BCT, Inc. | II | Nov-08-2017 |